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NOTES TO THE FINANCIAL STATEMENTS CONTINUED
For the financial year ended 30 June 2016
Note 28: Contingencies
There were no contingencies at 30 June 2016 (2015: nil).
Note 29: Subsequent events
The Board resolved to issue 1,000,000 options to the Chief Executive Officer (Mr Michael Kotsanis) on 22 July 2016 at an exercise price
of $0.96 per share. The options comprise the long term incentive component of the CEO’s remuneration package and were issued
pursuant to the terms of the Chief Executive Officer Share Option Plan, which was approved at the Acrux Limited Extraordinary
General Meeting held on 3 February 2015. Shares allocated on the exercise of these options will rank equally with the issued capital
of the Company from their date of exercise.
Formal trial proceedings concluded in July 2016 in the US District Court for the Southern District of Indiana against (1) Perrigo Israel
Pharmaceuticals Limited (Perrigo), (2) Watson Laboratories Inc. (Actavis), (3) Amneal Pharmaceuticals LLC (Amneal) and (4) Lupin
Pharmaceuticals Inc. (Lupin) (collectively, the ‘Defendants’), respectively for infringement of issued patents covering Axiron®. In each
instance, the patents are owned by Acrux DDS Pty Ltd, a wholly-owned subsidiary of Acrux Limited and exclusively licensed to Eli
Lilly and Company, our licensee for Axiron®. On 22 August 2016, the US District Court for the Southern District of Indiana ruled the
formulation and axilla application patents granted by the US Patent Office for Axiron® have been invalidated and therefore would not
be infringed by the commercialisation of generic versions of Axiron® by the generic companies that have challenged these patents.
The applicator patent is valid but not infringed by the majority of parties. The decision allows FDA-approved generic versions of
Axiron® to enter the US marketplace, pending an appeal. On 23 August 2016, in the United States, Eli Lilly and Company and Acrux
announced that they will appeal the Court’s decision. In the event that the decision is overturned during the appeal, and the courts
determine that the patents are valid and infringed, the generics can be withdrawn from the market and the brand company can seek
monetary damages. Appeal proceedings are ongoing at the time of writing this report.
There has been no other matter or circumstance, which has arisen since 30 June 2016 that has significantly affected or may
significantly affect:
(a) the operations, in financial years subsequent to 30 June 2016, of the consolidated entity; or
(b) the results of those operations; or
(c) the state of affairs, in financial years subsequent to 30 June 2016, of the consolidated entity.
Note 30: Company details
The registered office of the Company is:
Acrux Limited
103 – 113 Stanley Street
West Melbourne
Victoria 3003
60 ACRUX ANNUAL REPORT 2016